Appeals Court OKs Fed Funding of Embryonic-Stem-Cell Research

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Appeals Court OKs Fed Funding of Embryonic-Stem-Cell Research

By John Timmer, Ars Technica

A three-judge panel of a US Appeals Court lifted an injunction Friday against the National Institutes of Health's revised policy on the funding of stem cell research. The new policy, which would open up research funding to many more human embryonic-stem-cell linesm or hESCs, attracted a lawsuit from researchers who focus on adult stem cells, who claimed that their chances of obtaining grants had been diminished.

That suit produced an injunction that would block the NIH from distributing funding for hESC work. The Appeals Court had previously stayed this injunction. Now it has lifted it entirely, although the case is continuing towards trial at the district court level.

[partner id="arstechnica" align="right"]Legislation called the Dickey-Wicker Amendment has prevented the U.S. government for decades from funding research in which a human embryo is destroyed. Everyone agrees that this prohibits funding of work in which hESCs are derived through the destruction of fertilized eggs.

Differences arise, however, regarding research that involves hESCs that have been previously created. The George W. Bush administration determined that this is acceptable, provided that the ESC creation occurred prior to a specific date.

The Barack Obama administration lifted this temporal restriction. Work on previously created hESC lines then became eligible for funding, regardless of creation date.

This led a variety of groups to sue the NIH over its new policy, claiming it violated Dickey-Wicker. After a few preliminary decisions, however, only a pair of scientists remained involved in the lawsuit.

They were ruled to have standing to sue, because their work on adult stem cells would face increased competition for grant money from labs that were previously ineligible for federal funding. A district court awarded these plaintiffs a preliminary injunction that would block the NIH's new funding policy, ruling that they were likely to win their case (i.e., the policy did violate Dickey-Wicker) and were at risk of immediate harm, grantwise.

The appeals court stayed that injunction while it considered the NIH's appeal of the decision. Now, it has chosen to lift the injunction entirely (.pdf).

Everyone agrees that the relevant precedent for the new decision is Chevron v. NRDC, which states that rulings must take into account the "unambiguously expressed intent of Congress" and whether the relevant agency (in this case, the NIH) has interpreted that intent reasonably.

In this case, the intent in question is whether Congress meant to ban all research involving an hESC line created through the destruction of an embryo, or simply the destruction of an embryo. Using a dictionary definition of the term "research," the circuit court had determined that research in the broader sense was banned. A dissenting appeals judge also felt that way.

The majority, however, noted that Dickey-Wicker is written in the present tense, which implies that only the research involved in creating the ESC, rather than all future research involving it, is banned. "Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an ESC from an embryo," the decision reads, "it does not prohibit funding a research project in which an ESC will be used."

In general, Friday's ruling is in keeping with how scientists view the term "research," which focuses on the actual project at hand rather than the creation of all the equipment and materials needed to pursue it.

The appeals court also ruled that the plaintiffs were in no danger of harm as a result of the changed policy, because they had been competing against hESC researchers since 2001, when the Bush policy was first adopted.

This will allow the NIH to continue its plans to fund stem cell work while the district court continues to hear the case. Currently, both parties have requested summary judgments in their favor. Although the district judge has shown himself partial to the plaintiffs' arguments, the appeals aourt has sent a clear signal that some of them are unlikely to hold water, which may have a significant influence on any future decisions.

Left in place, however, is the ruling that let the case proceed in the first place: Researchers whose chances of funding are reduced by a change in policy still have the standing to sue the funding agency. Although this still requires that the potential litigants find a way to argue that the policy change violates a law, it opens the door to frivolous lawsuits from disgruntled researchers.

Image: Human embryo at progressive stages of growth, from four-cell to molura, blastocyst – the stage at which it's harvested for embryonic stem cells – and hatching blastocyst. (Cell Research)